The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be powered from an IEC 60601-1 compliant AC adaptor. The device inflates a cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During deflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure.

The device is intended to be used with Omron specified cuffs as specified below

Small 17-22cm arm cuff - circumference (PN: HEM-CS24)
Medium 22-42cm arm cuff circumference (PN: HEM-RML31) ●
. Extra Large (XL) cuff arm circumference 42-50cm (PN: HEM-RXL31)

The device also detects the appearance of irregular heartbeats during measurement.

The device can also send measurement data to third party applications. Transmission is via an integral FCC compliant Bluetooth Low Energy (BLE) module.

AI/ML Overview

Here's an analysis of the provided text regarding the Omron Healthcare, Inc. HEM-9210T device, focusing on the acceptance criteria and the study proving its performance.

Device: Omron Healthcare, Inc. HEM-9210T (Noninvasive blood pressure measurement system)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ANSI/AAMI/ISO 81060-2)	Reported Device Performance (HEM-9210T)
Accuracy of Pressure Indicator:	Within ±3 mmHg or 2 % of reading
Accuracy of Pulse Rate:	Within ±5 % of reading

Note: The document explicitly states that the device was tested for clinical accuracy in accordance with ANSI/AAMI/ISO 81060-2, and the results showed compliance to the standard. The reported performance values (±3 mmHg / 2% for pressure and ±5% for pulse rate) are consistent with the typical requirements of this standard for non-invasive blood pressure monitors.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 92 patients
Data Provenance: Not explicitly stated, but clinical testing was performed for "clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2." This standard outlines specific requirements for patient selection and testing methodology. It's likely a prospective study, as clinical accuracy testing of this nature is generally designed prospectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not explicitly provided in the given document. For blood pressure clinical validation studies following ISO 81060-2, typically a minimum of three trained observers independently measure blood pressure using a mercury sphygmomanometer or validated auscultatory device. Their qualifications are usually highly specialized, often requiring certification for blood pressure measurement validation.

4. Adjudication Method for the Test Set:

This information is not explicitly provided in the given document. In clinical validation studies of blood pressure monitors, the gold standard (ground truth) measurements taken by multiple observers are typically averaged or adjudicated through a specific protocol (e.g., if two out of three observers agree within a certain tolerance, that measurement is used; otherwise, re-measurement occurs).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers or image analysis. Therefore, an MRMC comparative effectiveness study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes. The document details "Clinical Testing Summary: Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2." This refers to the standalone performance of the device (algorithm only), comparing its measurements to a reference standard.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The ground truth used for the clinical accuracy testing would be provided by simultaneous, independent auscultatory measurements performed by trained observers (experts) using a reference sphygmomanometer, following the strict protocols of the ANSI/AAMI/ISO 81060-2 standard. This is essentially a form of expert consensus on the "true" blood pressure measurement at the time of the device reading.

8. The Sample Size for the Training Set:

This information is not explicitly provided in the document. The document describes clinical validation for final performance, not the internal development or training of the device's algorithms. Blood pressure monitors like this typically rely on established oscillometric principles and may be "trained" or calibrated on internal datasets during their development, but the specifics are not detailed here.

9. How the Ground Truth for the Training Set Was Established:

This information is not explicitly provided in the document, as no specific "training set" study is detailed for this device in the public filing. If a training set were used during device development, its ground truth would likely be established through similar methods as the test set: auscultatory measurements by trained clinical personnel.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 20, 2017

Omron Healthcare, Inc. % Paul Dryden, Consultant Promedic. LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134

Re: K163235

Trade/Device Name: HEM-9210T Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 22, 2017 Received: March 23, 2017

Dear Paul Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mude Jellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K163235

Device Name

Omron Healthcare HEM-9210T

Indications for Use (Describe)

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Type of Use (Select one or both, as applicable)

]Prescription Use (Part 21 CFR 801 Subpart D)

|X|Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "

FORM FDA 3881 (8/14

Page 1 of 1

SC Publishing Services (301) 443-6740

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

PDF PAGE 36 of 867

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510(k) Summary
Page 1 of 8
11/15/2016

Omron Healthcare, Inc.
1925 West Field Court
Lake Forest, IL 60045 USA
Official Contact:	Renee Thornborough – Executive Director QA/RA
Proprietary or Trade Name:	Model HEM-9210T
Common/Usual Name:	Noninvasive blood pressure measurement system.
Classification Name/Code:	DXN – Noninvasive blood pressure measurementsystem.21CFR 870.1130Class II
Device:	Model HEM-9210T
Predicate Device:	Omron HEM-7311 K133379

Device Description:

The device is intended to be used with Omron specified cuffs as specified below

Small 17-22cm arm cuff - circumference (PN: HEM-CS24)
Medium 22-42cm arm cuff circumference (PN: HEM-RML31) ●
. Extra Large (XL) cuff arm circumference 42-50cm (PN: HEM-RXL31)

The device also detects the appearance of irregular heartbeats during measurement.

The device can also send measurement data to third party applications. Transmission is via an integral FCC compliant Bluetooth Low Energy (BLE) module.

Intended User

Home user

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510(k) Summary Page 2 of 8 11/15/2016

Patient Population

This device is intended for use on adults.

Indications for Use:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Environment of Use:

Home

Contraindications:

There are no known contraindications.

Predicate Device Comparison:

The HEM-9210T was compared to the predicate HEM-7311- K133379 in the device comparison table below.

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K163235 Omron HEM-9210T

510(k) Summary Page 3 of 8 11/15/2016

Device Comparison

	Predicate Devices	New Device	Comparison
Model Name:	HEM-7311	HEM-9210T	-
510(k) Number	K133379	---	-
Indications	The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.	The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.	Identical
	Environmental of Use	Home	Home	Identical
	Patient Population	Adult	Adult	Identical

Specifications / Features

Specification	HEM-7311	HEM-9210T	Comparison
Measurement method	Cuff oscillometric method	Cuff oscillometric method	Identical
Measurement range	Pressure: 0 to 299 mmHgPulse Rate: 40 to 180 beats/min.	Pressure: 0 to 299 mmHgPulse Rate: 40 to 180 beats/min.	Identical
Pressure sensor	Semiconductor pressure sensor	Semiconductor pressure sensor	Identical
510(k) SummaryPage 4 of 811/15/2016
Specification	HEM-7311	HEM-9210T	Comparison
Applicable cuff(Arm Circumference)	17-22cm (HEM-CS24)22-32cm (HEM-CR24)22-42cm (HEM-RML31)	17-22cm (HEM-CS24)Cleared under K13337922-42cm (HEM-RML31)Cleared under K133379	Similar to predicate,additional range clinicallyvalidated.
		42-50cm (HEM-RXL31)(New)
Accuracy of pressure indicator	Within ±3 mmHg or 2 % of reading	Within ±3 mmHg or 2 % of reading	Identical
Accuracy of pulse rate	Within ±5 % of reading	Within ±5 % of reading	Identical
Inflation method	Automatic by electric pump	Automatic by electric pump	Identical
Deflation method	Automatic pressure release valve	Automatic pressure release valve	Identical
Display	LCD digital display	LCD digital display	Identical
Power Source	4"AA"batteries or AC adapter	4"AA"batteries or AC adapter	Identical
Operating conditions	10 to 40 °C15 to 90 %RH	10 to 40 °C15 to 90 %RH	Identical
Storage conditions	-20 to 60 °C10 to 95 %RH	-20 to 60 °C10 to 95 %RH	Identical
Dimensions (mm)	183 (W) × 230 (D) × 99 (H) mm	107 (W) × 141 (D) × 79 (H) mm	Similar in size. Size is not afactor in function of thedevice
Weight	Approx. 640g ( 1 lbs6 5/8 oz)(not including battery)	Approx. 290g (10oz)(not including battery)	Similar weight. Weight isnot a factor in function ofthe device
Irregular Heart beat Feature	Yes	Yes	Identical
Page 5 of 811/15/2016
Specification	HEM-7311	HEM-9210T	Comparison
Body movement detection	Yes	Yes	Identical
Hypertension indicator	Yes	No	This feature does not affectfundamental BPmeasurement function
Average of latest three measurements	Yes	No	This feature does not affectfundamental BPmeasurement function
Provides an average of 3measurements	Yes	No	This feature does not affectfundamental BPmeasurement function
Multiple Users	Yes (2)	No	This feature does not affectfundamental BPmeasurement function
Bluetooth	No	Yes	This feature does not affectfundamental BPmeasurement function
Power supply	Regulates power voltage regardless ofbattery voltage.	Regulates power voltage regardless ofbattery voltage.	Identical
Microprocessor	determines blood pressure andpulse ratecontrols the pump, the valve, andthe displaydetects switch operationsstores measurement resultsmanages date and time	determines blood pressure and pulseratecontrols the pump, the valve, andthe displaydetects switch operationsstores measurement resultsmanages date and time	Identical
Pressure sensor	Semiconductor pressure sensor	Semiconductor pressure sensor	Identical
Specification	HEM-7311	HEM-9210T	Comparison
Rapid exhaust valve / DeflationValve	Active electronic control valve thatperforms cuff air bleeding and release	Active electronic control valve thatperforms cuff air bleeding and release	Identical
Inflation source	DC rolling diaphragm pump	DC rolling diaphragm pump	Identical
Display	LCD (Liquid Crystal Display) displays;current cuff pressure systolic blood pressure diastolic blood pressure pulse rate error messages measurement results in thememory	LCD (Liquid Crystal Display) displays;current cuff pressure systolic blood pressure diastolic blood pressure pulse rate error messages	Similar, no memory function
Controls	START/STOP Button Date/Time setting Button Up/Down Button User ID Selections Button	START/STOP Button	Simplified
Cuff (included with device)	Soft Cuff(HEM-RML31) 22-42cm	Soft Cuff(HEM-RML31) 22-42cm	Identical
Biocompatibility of materials	Surface contactSkinLimited duration of use < 24 hours	Surface contactSkinLimited duration of use < 24 hours	Identical

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K163235 Omron HEM-9210T

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K163235 Omron HEM-9210T

510(k) Summary Page 6 of 8 11/15/2016

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510(k) Summary Page 7 of 8 11/15/2016

Differences Between Other Legally Marketed Predicate Devices:

The Omron HEM-9210T is viewed as substantially equivalent to the predicate device because: The HEM-9210T uses the exact same technology and has identical indications for use. The differences that exist between the devices do not raise new issues of safety or effectiveness

Indications -

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Discussion - These indications are identical to the predicate Omron HEM-7311 510(k) K133379

Prescriptive - The HEM-9210T and predicate are OTC.

Design and Technology - The HEM-9210T has equivalent design and features when compared to the predicate and has the identical technology to the predicate.

Performance and Specifications – The HEM-9210T has equivalent specifications of performance when compared to the predicate.

Materials -

The HEM-CS24 and HEM-RML31 cuffs are identical to the cuffs cleared in the predicate. The patient contacting materials of the cuffs inclusive of the HEM-RXL31 have been tested in accordance with ISO 10993-1 and FDA Guidance. The tests included Cytotoxicity, Sensitization, and Irritation

Patient Population -

The HEM-9210T and predicate are indicated for adults

Environment of Use - Home, Identical to the predicate

Compliance with standards The HEM-9210T and predicate comply with AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, and ANSI/AAMI/ISO 81060-2.

Differences -

There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.

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510(k) Summary Page 8 of 8 11/15/2016

Performance Testing

Non-clinical Testing

Bench

We have performed bench tests and found that the HEM-9210T met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate. Testing includes the following:

Verification Testing
Testing for compliance to AAMI ES 60601-1
Testing for compliance to IEC 60601-1-2, ●
Testing for compliance to IEC 60601-1-11
Testing for compliance to IEC 80601-2-30 ●
. Comparative Testing to the predicate

The results demonstrate that the devices perform as intended are substantially equivalent to the performance of the predicate and in accordance with applicable standards.

Biocompatibility of Materials -

The patient contacting materials of the cuff have been tested in accordance with ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation.

ISO 10993-1 considered the patient contacting as Surface, Skin, Limited duration of use.

Human Factors / Usability

We performed usability with 18 lay users. There were no failures, user errors or near misses.

Clinical Testing Summary:

Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2.

This testing was performed on 92 patients with results showing compliance to the standard.

Substantial Equivalence Conclusion

Omron maintains that the HEM-7311 is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).